Regulatory Focus™ > News Articles > Regulatory Recon: FDA Launches GDUFA Stakeholder Meetings (3 June 2015)

Regulatory Recon: FDA Launches GDUFA Stakeholder Meetings (3 June 2015)

Posted 03 June 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: FDA Launches GDUFA Stakeholder Meetings (3 June 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • FDA Launches GDUFA Stakeholder Meetings (FDA)
  • White House Meeting Elicits Pledges to Reduce Antibiotic Use (NYTimes) (SCRIP-$) (White House)
  • Guidance: Veterinary Feed Directive Regulation - Questions and Answers (FDA) (FR)
  • Antibiotic Incentives Moving Forward: “Cures” Act Pathway May Apply More Broadly (RPM Report-$)
  • FDA Looking to Hire New Director for its Biologic Program (FDA)
  • Eve of Oral Argument in Dispute Over BPCIA Provisions (FDA Law Blog)
  • Which State is Winning the 510(k) Race? (MDDI)
  • Report: Computerized Clinical Decision Support Systems Fail at Spectacular Rate (IEEE)
  • FDA Warning Letter Hits Software Company for Lack of Testing (FDA)

In Focus: International

  • MHRA Grants EAMS Approval to BMS' Nivolumab (MHRA)
  • IQWiG unimpressed with Tresiba for children (PMLive)
  • Bulgaria and Romania will now team up to conduct joint drug price negotiations (Politico)
  • Approval of revisions to key EU clinical investigation guidelines just out of reach (Clinica-$)
  • DePuy Synthes warns on knee implants (Mass Device)
  • Pharmaceutical Kol Disclosure Requirements: Global Transparency Trends (CEI)
  • A Modern Risk-based Monitor (Polaris)

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US: Pharmaceuticals and Biotechnology (In-Pharma)

  • White House Meeting Elicits Pledges to Reduce Antibiotic Use (NYTimes) (SCRIP-$) (White House)
  • Guidance: Veterinary Feed Directive Regulation - Questions and Answers (FDA) (FR)
  • Antibiotic Incentives Moving Forward: “Cures” Act Pathway May Apply More Broadly (RPM Report-$)
  • FDA Launches GDUFA Stakeholder Meetings (FDA)
  • FDA Looking to Hire New Director for its Biologic Program (FDA)
  • Eve of Oral Argument in Dispute Over BPCIA Provisions (FDA Law Blog)
  • FDA Addresses Concerns on Approval of Drugs to Treat Chronic Hepatitis C (Press) (Wiley)
  • The US drug shortage — by the numbers (PharmPro)
  • Ostroff: Antimicrobial Resistance at a "Tipping Point" (RPM Report-$)
  • FDA panel to discuss Lilly's lung cancer drug approval (Reuters)
  • Regulatory Considerations in Optimizing a Site for Mobile (EyeOnFDA)
  • FDA Extends Comment Period on Pharmaceutical Compounding MOU (FDA)
  • US pharma suppliers prepare for new GMP excipients standard (SCRIP RA-$)
  • Three More Compounders Warned for Sterility Issues, Bringing Total to a Dozen (FDAnews-$)
  • FDA Approval for New ADHD Generic Drug (Press)
  • FDA Approval for Generic Oxycodone HCl (Press)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • AstraZeneca Near Decision on Suicide-Linked Drug, CEO Says (Bloomberg)
  • MediciNova Announces FDA Granted Orphan Drug Designation to MN-166 (ibudilast) for Krabbe Disease (Press)
  • Aptose Biosciences Granted Orphan Drug Designation by the U.S. FDA for APTO-253 in Acute Myeloid Leukemia (Press)

US: Medical Devices

  • Which State is Winning the 510(k) Race? (MDDI)
  • Report: Computerized Clinical Decision Support Systems Fail at Spectacular Rate (IEEE)
  • Top 5 steps for medical device manufacturers to operationalize their cybersecurity programs (MassDevice)
  • Business Strategy for Unique Device Identifier Adoption (MDDI)
  • FDA Warning Letter Hits Software Company for Lack of Testing (FDA)
  • Coalition, FDA Talk Alternative LDT Approach; But Proposal Lacks Support in Congress (IHP-$)
  • House panel votes to repeal health law's medical device tax (AP)
  • Cohero Health gets FDA clearance for smartphone-connected spirometer (MobiHealthNews)
  • Monarch Medical Technologies Receives FDA 510(k) Clearance for EndoTool SubQ (Press)

US: Assorted And Government

  • U.S. tobacco companies drop lawsuit vs FDA over labeling (Reuters)
  • Regulatory Oversight Legislation Introduced in Congress (The Hill)
  • State Efforts to Promote Organ Donation Mostly Fizzle (MedPage Today) (Reuters)
  • Vaccine Court Aims To Protect Patients And Vaccines (NPR)

Upcoming Meetings and Events

Europe

  • MHRA Grants EAMS Approval to BMS' Nivolumab (MHRA)
  • IQWiG unimpressed with Tresiba for children (PMLive)
  • Bulgaria and Romania will now team up to conduct joint drug price negotiations (Politico)
  • Approval of revisions to key EU clinical investigation guidelines just out of reach (Clinica-$)
  • Amicus Therapeutics Submits Marketing Authorization Application (MAA) for Full Approval of Fabry Monotherapy Galafold (Migalastat) in European Union (Press)
  • NICE: people should be more involved in medical decisions (Press)
  • NICE issues final guidances in DME (BioCentury)
  • NICE recommends Boehringer's VARGATEF (nintedanib) in combination with docetaxel as an option for patients with non-small cell lung cancer of adenocarcinoma histology within its licensed indication (Press)

Australia

  • DePuy Synthes warns on knee implants (Mass Device)
  • Time running out for IVD makers in Australia to put house in order (SCRIP RA-$)

Other International

  • Pharmaceutical Kol Disclosure Requirements: Global Transparency Trends (CEI)
  • IEC TR 60601-4-3:2015 Guidance & interpretation of IEC 60601-1, 3rd ed. Published (Eisner)

Clinical Trials

  • A Modern Risk-based Monitor (Polaris)

General Regulatory And Interesting Articles

  • A Look at Why People Who Wear Contact Lenses Tend to Get So Many Eye Infections (CBS)

Regulatory Reconnaissance #568 – 3 April 2015

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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